Incyte’s Zynyz Receives the EC Approval to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

Shots: The EC has approved Zynyz (retifanlimab) + Pt-based CT for the 1L treatment of adults with metastatic or inoperable locally recurrent SCAC Approval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + carboplatin & paclitaxelvs PBO & CT in treatment-naïve SCAC pts The trial showed a 37% reduction in the risk of progression or…

ByRidhi RastogiMarch 9, 2026

NEWS

The CHMP Recommends Incyte’s Zynyz to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

Shots: The CHMP has recommended Zynyz (retifanlimab) + Pt-based CT as 1L treatment of adults with metastatic or with inoperable locally recurrent SCAC Opinion was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + carboplatin & paclitaxelvs PBO & CT in treatment-naïve SCAC pts P-III trial showed a 37% PFS improvement (mPFS: 9.3 vs 7.4mos.); data…

ByRidhi RastogiFebruary 3, 2026

NEWS

Incyte Reports the Topline P-III (frontMIND) Trial Data on Monjuvi (Tafasitamab) Combination for Diffuse Large B-Cell Lymphoma

Shots: The P-III (frontMIND) trial assessed Monjuvi (Minjuvi in EU) + lenalidomide & R-CHOP vs R-CHOP as the 1L treatment in ~900 adults with previously untreated DLBCL (IPI score of 3-5 for pts >60yrs or aaIPI of 2-3 for pts ≤60yrs.) Trial met its 1EP of improved PFS by investigator assessment & achieved its key…

ByRidhi RastogiJanuary 6, 2026

NEWS

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R Follicular Lymphoma (FL)

Shots: The MHLW has approved Incyte’s Minjuvi + rituximab & lenalidomide for the treatment of adults with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Approval was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL or r/r nodal, splenic or extranodal MZL…

ByRidhi RastogiDecember 23, 2025

NEWS

Incyte’s Minjuvi (Tafasitamab) Combination Gains the EC Approval for R/R Follicular Lymphoma (FL)

Shots: The EC has approved Incyte's Minjuvi + rituximab & lenalidomide for the treatment of adults with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Approval was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL or r/r nodal, splenic or extranodal MZL…

ByRidhi RastogiDecember 18, 2025

NEWS

Incyte Reports Positive P-I Data of INCA033989 in Essential Thrombocythemia (ET) at ASH 2025

Shots: Incyte reported updated data from two P-I trials showing the safety, tolerability, and efficacy of INCA033989 (INCA33989-101 and INCA33989-102) in 455 adults(age≥18) with mutCALR-positive MPNs, including ET & MF, findings were presented at ASH'25 In ET pts receiving higher starting doses of INCA033989 (400–2,500 mg; n=30), 90% achieved a HR, including 83.3% with CHR…

ByDipanshu DixitDecember 9, 2025

NEWS

Incyte’s Minjuvi Combination Gains the CHMP’s Positive Opinion for R/R Follicular Lymphoma (FL)

Shots: The CHMP has recommended Minjuvi (tafasitamab) + rituximab & lenalidomide for the treatment of adult pts with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Opinion was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL (n=548) & r/r nodal, splenic or…

ByRidhi RastogiNovember 17, 2025

NEWS

Incyte Partners with Enable Injections for enFuse On-Body Delivery System

Shots: Incyte has partnered with Enable Injections to develop and commercialize specific assets in Incyte’s portfolio, incl. INCA033989, a mutCALR selective mAb, with Enable’s enFuse On-Body Delivery System As per the deal, Incyte will obtain exclusive global rights to use enFuse tech with INCA033989 for essential thrombocythemia & myelofibrosis, with potential expansion to other assets &…

ByRidhi RastogiOctober 28, 2025

NEWS

Incyte Reports the Health Canada’s Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Shots: Health Canada has approved Opzelura cream 1.5% for the treatment of mild to mod. AD in children (≥2yrs.), when other topical therapies are ineffective or unsuitable Approval was based on the P-III (TRuE-AD3) trial, evaluating Opzelura (BID) vs vehicle in over 300 children (≥2 to <12yrs.) with AD Trial met its 1EP with more…

ByRidhi RastogiOctober 16, 2025

NEWS

Incyte Reports the US FDA’s sNDA Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Shots: The FDA has approved Opzelura cream 1.5% for short-term and non-continuous treatment of mild to moderate AD in non-immunocompromised children (aged≥ 2), when other topical therapies are ineffective or unsuitable sNDA approval was based on the P-III (TRuE-AD3) trial which evaluated the safety and efficacy of ruxolitinib in over 300 children receiving 0.75%, 1.5%,…

ByDipanshu DixitSeptember 19, 2025

Incyte’s Zynyz Receives the EC Approval to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

The CHMP Recommends Incyte’s Zynyz to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

Incyte Reports the Topline P-III (frontMIND) Trial Data on Monjuvi (Tafasitamab) Combination for Diffuse Large B-Cell Lymphoma

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R Follicular Lymphoma (FL)

Incyte’s Minjuvi (Tafasitamab) Combination Gains the EC Approval for R/R Follicular Lymphoma (FL)

Incyte Reports Positive P-I Data of INCA033989 in Essential Thrombocythemia (ET) at ASH 2025

Incyte’s Minjuvi Combination Gains the CHMP’s Positive Opinion for R/R Follicular Lymphoma (FL)

Incyte Partners with Enable Injections for enFuse On-Body Delivery System

Incyte Reports the Health Canada’s Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Incyte Reports the US FDA’s sNDA Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

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